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VOXILAPREVIR PATENT LANDSCAPE: a Scoping Report

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VOXILAPREVIR PATENT LANDSCAPE: a Scoping Report Review of the VOXILAPREVIR PATENT LANDSCAPE: A scoping report March 2017 CONTENTS © 2017 World Health Organization (Acting as the host organization for the Secretariat of UNITAID) The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. This report was prepared by Andrew Brown and Amel Garbi (Pharmathen) with input from Karin Timmermans (UNITAID). All reasonable precautions have been taken by the authors and the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall UNITAID or the World Health Organization be liable for damages arising from its use. CONTENTS Abbreviations 4 I. Introduction 5 II. Methodology 6 III. Background 7 Hepatitis C virus 7 Voxilaprevir 9 IV. Overview of voxilaprevir patents 10 V. Analysis of voxilaprevir patents/applications 12 ANNEX 1. VOXILAPREVIR patent situation in countries 27 4 ABBREVIATIONS I. DAA direct-acting antiviral EPO European Patent Office HCV hepatitis C virus HIV human immunodeficiency virus NS non-structural PCT Patent Cooperation Treaty PEG-interferon Pegylated interferon RNA ribonucleic acid 5 I. INTRODUCTION Hepatitis C is a major global health These DAAs generate cure rates that problem; some 130−150 million people approach or exceed 90 per cent. Some worldwide are chronically infected with combination regimens may have pan- the hepatitis C virus (HCV). It is estimated genotypic efficacy, which would simplify that, worldwide, 2.9 million people treatment and monitoring. One compound are coinfected with HIV and HCV. Each of interest is Gilead’s investigational year, approximately 700,000 people compound GS-9857, or voxilaprevir. die of HCV-related liver disease, and evidence indicates that the HCV burden In view of its potential role in future is increasing.1,2,3 While the HCV epidemic treatment, this report explores the patent is global in scope, the HCV burden varies landscape of voxilaprevir. considerably between countries. The virus has six primary genotypes. Genotypes 1 and 3 are the most prevalent, accounting respectively for 46 per cent and 30 per cent of HCV cases worldwide. Together, genotypes 2, 4 and 6 represent around 23 per cent of HCV cases, while genotype 5 accounts for less than 1 per cent.4 Efforts to treat HCV have historically been hampered by suboptimal and inadequate treatments. However, the development of direct-acting antivirals (DAAs) has dramatically improved the prospects for HCV treatment and has altered the standard of care. Several new DAAs that do not require Pegylated interferon (PEG- interferon) have been launched since late 2013, and a number of other DAAs are in development. 1. Hepatitis C factsheet. Geneva: World Health Organization; July 2016 (http://www.who.int/mediacentre/factsheets/fs164/en/, accessed 29 January 2017). 2. Global health sector strategy on viral hepatitis 2016−2021. Geneva: World Health Organization; 2016. 3. GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age–sex specific all-cause and cause-specific mortality for 240 causes of death, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;385(117−71). 4. Messina JP, Humphreys I, Flaxman A, Brown A, Cooke GS, Pybus OG et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology. 2014;61(1):77−87. 6 II. METHODOLOGY III. Relevant patents and patent applications were updated in February 2017. were identified by searching patent and non-patent databases, namely: SciFinder, Caveat: It is important to note that the PatBase, TotalPatent and Google Patents. patent status of a given product in a given Searches were carried out using keywords, country may change and that data may semantic searches, International Patent therefore become outdated. It is advisable Classification (IPC) searches, chemical always to check with the relevant national structure searches and combinations or regional patent office for the most thereof. up-to-date information on the status of a given patent or patent application. For each of the most relevant patent and/ or applications, the equivalents were This report was prepared by Andrew identified (INPADOC family) and the legal Brown and Amel Garbi (Pharmathen), with status of each of the equivalents was input from Karin Timmermans (UNITAID). checked on the websites of the relevant The patent searches were conducted by patent offices. The countries listed in Amel Garbi. Pascale Boulet updated the Annex 1 represent those for which data are searches for Patent 2 and 3. available. Peter Beyer and Pascale Boulet reviewed The searches were performed in December a draft version of this report, and provided 2015. Information for Patent 1 was valuable input and suggestions. complemented with data from Form 3 submitted to the Indian Patent Office in April 2016. Searches for Patents 2 and 3 7 III. BACKGROUND Hepatitis C virus (core, E1 and E2), the ion channel protein p7, and six non-structural (NS) proteins (NS2, NS3, NS4A, NS4B, NS5A and NS5B) The hepatitis C virus is a small (55−65 nm), (see Figure 1). Each of these proteins plays enveloped, positive-sense, single-stranded a role in HCV entry, infection, replication RNA virus of the Flaviviridae family. The or maturation and is therefore a potential virus consists of three structural proteins target for medicines. Figure 1. Hepatitis C virus RNA 9600 nt bases Gene encoding precursor polyprotein 5’ NTR Structural proteins Non-structural proteins 3’ NTR p22 gp35 gp70 p7 p23 p70 p8 p27 p56/58 p68 C E1 E2 NS1 NS2 NS3 NS4A NS4B NS5A NS5B Envelope transmembrane co-factors RNA glycoproteins protein polymerase Nucleocapsid proteases interferon resisting RNA helicase protein Adapted from Graham Colm. 8 DAAs block viral production by directly for boceprevir or telaprevir with PEG- inhibiting one or more steps of the HCV interferon and ribavirin were higher than replication cycle. DAAs can be divided those of PEG-interferon and ribavirin, into categories – notably NS3/NS4A but side-effects could be severe and serine protease inhibitors, NS5A complex some patients were obliged to stop the inhibitors and NS5B RNA polymerase treatment. inhibitors (both nucleoside and non- nucleoside). Second-wave and second-generation HCV protease inhibitors appear to hold promise HCV NS3 (serine) protease is one of the as they prove to be more potent, less prone most, if not the most, intensively studied to resistance, more convenient (most are anti-HCV targets, possibly because it is one once-daily) and more tolerable than the of the best-characterized HCV enzymes earlier drugs in this class. One of these but also because of the successful use newer protease inhibitors is voxilaprevir. of protease inhibitors as anti-HIV agents. NS3/4A protease inhibitors work by blocking a viral enzyme (protease) that enables the hepatitis C virus to survive and In December 2016, Gilead submitted a replicate in host cells. new drug application to the US Food and Drug Administration for the fixed-dose Several inhibitors of HCV NS3/4A protease combination sofosbuvir/velpatasvir/ have been identified and developed. voxilaprevir for treatment of HCV The first-generation protease inhibitors genotypes 1−6.5 In January 2017, the (boceprevir and telaprevir) were approved European Medicines Agency reportedly for administration in combination with granted accelerated assessment for PEG-interferon and ribavirin. Cure rates sofosbuvir/velpatasvir/voxilaprevir.6 5 Gilead submits new drug application to U.S. Food and Drug Administration for the investigational single tablet regimen sofosbuvir/velpatasvir/ voxilaprevir. Business Wire. 8 December 2016. 6 European Medicines Agency Validates Gilead’s Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Sofosbuvir/ Velpatasvir/Voxilaprevir (SOF/VEL/VOX). Business Wire. 20 January 2017. 9 Voxilaprevir against all genotypes. It also appears to have an improved resistance profile compared to other HCV protease inhibitors Voxilaprevir (formerly known as GS-9857) (PIs).7 is a novel, fluorinated macrocyclic HCV NS3/4A protease inhibitor in clinical The chemical structure of voxilaprevir is development that is showing efficacy shown in Figure 2. Figure 2. Structure of voxilaprevir Chemical name: (1aR,5S,8S,9S,10R,22aR)-5-tert-butyl-N-{(1R,2R)-2-(difluoromethyl)-1-{[(1-methylcyclopropyl) sulfonyl]carbamoyl}cyclopropyl}-9-ethyl-18,18-difluoro-14-methoxy-3,6-dioxo-1,1a,3,4,5 ,6,9,10,18,19,20,21,22,22a-tetradecahydro-8H-7,10-methanocyclopropa [18,19][1,10,3,6] dioxadiazacyclononadecino[11,12-b]quinoxaline-8-carboxamide. Molecular formula: C40H52F4N6O9S. Molecular weight: 766.9034 g/mol. CAS registry number: 1535212-07-7. 7 Gilead Sciences. Evaluation of transporter and cytochrome P450-mediateddrug-drug interactions with the pan-genotypic HCV NS3/4A protease inhibitor voxilaprevir (GS-9857) or sofosbuvir/velpatasvir/voxilaprevir and phenotypic probe drugs. Presentation at the 17th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy, June 2016, Washington DC, quoting Taylor JG et al., EASL 2015, poster 899. 10 OVERVIEW OF IV. VOXILAPREVIR PATENTS Four patents and/or patent applications cirrhosis by administering to the subject an related to voxilaprevir appear to be the effective amount of sofosbuvir. In various most relevant. These patents/applications methods, sofosbuvir can be concomitantly include the patent/application covering administered with at least one additional the compound per se. Patents/ anti-HCV agent.
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